IEC 62304 Expert (Design Assurance Engineer)

Job Description

Job Description

IEC 62304 Quality Specialist (Design Assurance Engineer)

No C2C. Fulltime permanent role (no sponsorship). Note: non-medical device industry exp application will NOT be considered.

Overview

We are looking a highly skilled IEC 62304 expert as Software Quality Engineer to work in Austin, TX (Onsite).

MUST Have: hands-on experience with

• IEC 62304 (Medical Device Software Life Cycle Processes)
• ISO 14971 (Risk Management for Medical Devices)
• ISO 13485 (Quality Management Systems)
• FDA 21 CFR Part 820 (Quality System Regulation)

This role will ensure the highest standards of medical devices software quality, safety, cybersecurity and compliance for medical device products. In this role, you will collaborate closely with cross-functional teams to support the full software development lifecycle, from design and risk management to verification, validation, and regulatory submission. You will apply your expertise in regulatory standards, software quality processes, and system-level thinking to ensure that our products meet both user needs and global regulatory requirements.

Key Responsibilities

• Ensure full compliance with global medical device regulations and standards, including:

1. IEC 62304 (Medical Device Software Life Cycle Processes)

2. ISO 14971 (Risk Management for Medical Devices)

3. ISO 13485 (Quality Management Systems)

4. FDA 21 CFR Part 820 (Quality System Regulation)

5. 21 CFR Part 11 (Electronic Records and Signatures)

6. Cybersecurity guidance for medical devices (e.g., FDA premarket guidance, AAMI TIR57/97, etc.)

• Review, maintain, and improve Quality System procedures and work instructions governing software development, validation, and lifecycle management for embedded, standalone, and cloud-based medical device software.
• Partner closely with cross-functional teams including R&D, Systems Engineering, Regulatory Affairs, Manufacturing, and Clinical teams to ensure that software development activities are fully integrated with design controls and compliant with applicable standards.
• Review and approve software design documentation, including:

1. Software Development Plans

2. Software Requirements Specifications (SRS)

3. Software Architecture and Design Documents

4. Risk Management documentation (including Software Failure Modes and Effects Analysis)

5. Verification and Validation protocols, test plans, test cases, and reports.

• Conduct software quality audits and assessments to ensure compliance with internal processes, SOPs, and applicable regulatory requirements.
• Actively participate in software risk management processes, facilitating hazard analyses, failure mode assessments, and risk mitigations throughout the product lifecycle.
• Provide oversight and review of process validation protocols for software systems used in manufacturing, testing, installation, service, and support of medical devices.
• Support regulatory submissions including 510(k), PMA, CE Technical Files, and international regulatory dossiers, ensuring complete and compliant software documentation.
• Participate in usability testing, clinical lab evaluations, cadaveric labs, and design validation activities to ensure software meets intended use and user needs.
• Provide expert guidance to teams during internal and external audits (e.g., FDA inspections, Notified Body audits, MDSAP audits).
• Assist in design transfer activities to ensure smooth transition from product development to manufacturing with appropriate validation of test methods, process controls, and inspection methods.
• Provide statistical analysis and support for software defect trending, CAPA investigations, and continuous improvement activities.

Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, or related technical discipline. Master’s degree preferred.
• Minimum 5+ years of hands-on experience as a Software Quality Engineer in the medical device industry (Class II and/or Class III devices preferred).
• In-depth knowledge of design controls, risk management, and software lifecycle processes specific to regulated medical devices.
• Demonstrated experience with IEC 62304-compliant software development and verification/validation processes.
• Strong working knowledge of ISO 14971, ISO 13485, 21 CFR Part 820, and current FDA guidance documents related to software in medical devices.
• Prior experience supporting 510(k), PMA, EU MDR, or other international regulatory submissions for medical device software.
• Ability to collaborate effectively with cross-functional teams and communicate quality requirements clearly to both technical and non-technical stakeholders.
• Excellent written, verbal, and interpersonal communication skills.
• Certified Software Quality Engineer (CSQE), ASQ, RAC, or other relevant certifications are a plus.

Preferred Experience (Nice to Have)

• Experience with connected medical devices, or software as a medical device (SaMD).
• Familiarity with cybersecurity frameworks applicable to medical device software.
• Experience with cloud-based or mobile medical applications.
• Direct interaction with FDA, Notified Bodies, or MDSAP auditors during inspections.